Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (Geometry Mono-1)

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    368
  • sponsor
    Novartis Pharmaceuticals
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Updated on 26 October 2020
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Investigator
Kondal Reddy
Primary Contact
Georgetown University Lombardi Cancer Center (7.8 mi away) Contact
+162 other location
measurable disease
metastasis
EGFR
alopecia

Summary

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

Details
Treatment INC280 (capmatinib)
Clinical Study IdentifierNCT02414139
SponsorNovartis Pharmaceuticals
Last Modified on26 October 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
Stage IIIB or IV NSCLC (any histology) at the time of study entry
Histologically or cytologically confirmed diagnosis of NSCLC that is
EGFR wt as per patient standard of care by a validated test
AND ALK-negative rearrangement as part of the patient standard of care by a validated test
AND (by central assessment) either
Cohort 1: Pre-treated patients with cMET GCN 6 or
Cohort 2: Pre-treated patients with cMET GCN 4 and < 6, or
Cohort 3: Pre-treated patients with cMET GCN < 4, or
Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN, or
Cohort 5: Treatment-nave patients with cMET dysregulation, or
Cohort 6: Pre-treated patients with either cMET GCN 10 without cMET mutations or cMET mutations regardless of cMET GCN, or
Cohort 7: Treatment-nave patients with cMET mutations regardless of cMET GCN
To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
To be eligible for Cohort 6, patients must have failed one prior line of systemic therapy for advanced/metastatic disease
To be eligible for Cohort 5 and Cohort 7, patients must not have received any systemic therapy for advanced/metastatic disease
At least one measurable lesion as defined by RECIST 1.1
Patients must have recovered from all toxicities related to prior anticancer therapies to grade 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study
Patients must have adequate organ function
ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion criteria may apply

Exclusion Criteria

Prior treatment with crizotinib, or any other cMET or HGF inhibitor
Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
Patients with characterized ALK-positive rearrangement
Clinically significant, uncontrolled heart diseases
Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study
Strong inducers of CYP3A4
Impairment of GI function or GI disease that may significantly alter the absorption of INC280
Patients receiving treatment with any enzyme-inducing anticonvulsant
Applicable to Cohorts 1-4 and Cohort 6 only: Previous anti-cancer and investigational agents within 4 weeks or 5 x half-life of the agent (whichever is longer) before first dose
Pregnant or nursing women
Women of child-bearing potential, unless they are using highly effective methods of contraception
Sexually active males unless they use a condom during intercourse
Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
Other protocol-defined exclusion criteria may apply
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